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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K131375
Device Name AUTOLAP SYSTEM
Applicant
MST - MEDICAL SURGERY TECHNOLOGIES LTD.
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Applicant Contact John j Smith, M.D., J.D.
Correspondent
MST - MEDICAL SURGERY TECHNOLOGIES LTD.
555 THIRTEENTH STREET NW
WASHINGTON,  DC  20004
Correspondent Contact John j Smith, M.D., J.D.
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/13/2013
Decision Date 09/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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